Stable cleanser compositions containing sulfur

ABSTRACT

The present invention is a composition, preferably a cleanser, comprising sulfur, sodium sulfacetamide and at least one emulsifier with a low HLB number. These compositions are stable and may include moisturizers and humectants. Use of these compositions include treatments for acne rosacea, acne vulgaris and other skin disorders.

FIELD OF THE INVENTION

The present application is a continuation of U.S. patent applicationSer. No. 11/253,482, filed on Oct. 19, 2005, which is a divisional ofU.S. Pat. No. 7,479,289, filed on Jul. 2, 2004, the entire contents ofwhich are hereby expressly incorporated herein by reference thereto.

The present invention relates to stable cleanser compositions useful inthe treatment and prevention of acne vulgaris, acne rosacea, otherdermatological disorders and their manifestations in the skin. Cleansersare particularly attractive as treatments for these disorders,especially if the active ingredients may be sufficiently delivered tothe skin in the short time a cleanser contacts the skin. Patientcompliance may be higher than usual because only a cleanser is requiredas opposed to two products, a cleanser and then a composition with theactive ingredient.

BACKGROUND OF THE INVENTION

The use of sulfur in dermatological products has been known for manyyears. The sulfur may be useful on dermatological disorders such as acnevulgaris, acne rosacea, mite infestations and other conditions. Sodiumsulfacetamide is also often used in combination with sulfur for thetreatment and/or prevention of such dermatological disorders. However,there are several problems with sulfur formulations in the prior art.

First, sulfur and sodium sulfacetamide may degrade into malodorouscomponents, such as sulfanilamide. Chemical and physical stability forsulfur and sodium sulfacetamide compositions has been difficult toachieve. Many sulfur compositions degrade, turn color and becomemalodorous in a relatively short time, which is undesirable toconsumers.

Patients frequently use sulfur and sodium sulfacetamide compositions onthe face and other skin. In order to promote compliance, it is desirableto have non-malodorous and aesthetically pleasing compositions.

Sulfur and sodium sulfacetamide compositions in the art have employedgums, clays, silicates and other sorptive materials in order to promotestability of the sulfur and sodium sulfacetamide. However, the stabilityprovided by these sorptive materials is limited and often not conduciveto cleanser compositions. In certain embodiments without limitation, thepresent invention does not comprise gums, clays, silicates and othersorptive materials.

Sorptive materials are defined to include those materials which, whenapplied topically to the skin, absorb irritants, including but notlimited to sweat, sebum, oil and dirt, from the skin.

Sulfur and sodium sulfacetamide compositions in the art frequently useemulsifiers with HLB (“Hydrophilic Lipophilic Balance”) numbers ofaround 30 or combined HLB numbers of about 30 or higher. However,chemical and physical stability appear to suffer in these compositions.

HLB Numbers

An HLB number referred to in this specification is calculated in themanner developed by William Griffin and used by ICI Americas, Inc.(“ICI”). It is well-known in the art and conventionally calculated andpublished. See, Griffin, W. C. “Classification of Surface-Active Agentsby HLB,” J. Soc. Cosmet. Chem. 1, 311-326 (1949); and Griffin, W. C.“Calculation of HLB Values of Non-Ionic Surfactants,” J. Soc. Cosmet.Chem. 5, 249-256 (1954) (incorporated herein by reference). ICI haspublished numerous reference materials regarding the HLB number.

The HLB number is an indication of the hydrophilic portion of anemulsifier molecule. The HLB number indicates the polarity of themolecules in a 1-20 range, and the number increases with increasinghydrophilicity. HLB numbers are usually calculated or obtainedexperimentally for nonionic surfactants. However, HLB numbers are oftenassigned up to 40 for ionic surfactants. These numbers over 20 arerelative or comparative numbers, which are not based on strictmathematical formulas, but are conventionally known and used. If anonionic emulsifier were 100% hydrophilic, the HLB number would be 20,because the factor ⅕ is used (e.g. ⅕ of 100). An emulsifier that islipophilic has a HLB number of below about 9 and one that is hydrophilichas a HLB number of above about 11. Those in the range of about 9-about11 are indeterminate. ICI publishes the HLB number of many of itsemulsifiers, and the other are calculable using the ICI method, which isknown in the art. ICI also set forth the following information regardingthe uses of emulsifiers.

TABLE 1 HLB Range Use 4-6 Water/Oil Emulsifiers 7-9 Wetting Agent  8-18O/W Emulsifiers 13-15 Detergents 10-18 Solubilizers

When two or more emulsifiers are combined, the resulting combined HLBnumber is calculated by adding (the percentage of emulsifier(1)multiplied by HLB(1)) and (the percentage of emulsifier(2) multiplied byHLB(2)). This can be calculated for any number of emulsifiers which arecombined.

HLB numbers can help predict what are the appropriate emulsifiers to usein a particular instance. The chemical type of the emulsifier also playsan important role in the most effective emulsifiers as is understood byone of ordinary skill in the art. In fact, the most stable emulsifiersystems usually consist of combinations of two or more emulsifiers, aportion with lipophilic tendencies and a portion with hydrophilictendencies.

ICI also provides the following guidance on dispersibility in water.

TABLE 2 HLB by Dispersibility HLB Range No dispersibility in water 1-4Poor dispersion 3-6 Milky dispersion after 6-8 vigorous agitation Stablemilky dispersion  8-10 Translucent to clear 10-13 dispersion Clearsolution 13+

Preparing stable emulsions, as is known to those of ordinary skill inthe art, is an inexact and time-consuming process. To date, sulfur andsodium sulfacetamide compositions, which are emulsions, and particularlycleansers, have shown a tendency to be unstable, physically andchemically. The present invention achieves a surprising stability forsuch compositions, along with the additional benefit of beingaesthetically pleasing and dermatologically desirable.

SUMMARY OF THE INVENTION

The present invention includes a stable composition comprising sulfur,sodium sulfacetamide, and at least one emulsifier, which has a low HLBnumber. A low HLB number is less than about 8, more preferably less thanabout 5, and most preferably about 4.7 and below. The preferred amountof sulfur is up to about 5% by weight (all percentages in thespecification are by weight unless otherwise noted), most preferablyabout 5% with appropriate overage amounts to satisfy FDA requirements ofa composition labeled 5% sulfur. The preferred amount of sodiumsulfacetamide is up to about 10%, most preferably about 10% withappropriate overage amounts to satisfy FDA requirements of a compositionlabeled 10% sodium sulfacetamide. The pH of the composition ispreferably about 5.0 to about 8.0, and more preferably about 7.0.

Emulsifiers are characterized according to the balance of thehydrophilic and lipophilic parts. In this specification, the termemulsifiers may also include surfactants, which behave as emulsifiersbut may not be formally called emulsifiers. In the present invention, atleast one emulsifier must have a low HLB number. “High” HLB number meansabout 35 to about 40.

Emulsifiers, which have low HLB numbers and may be suitable to thiscomposition include but are not limited to sorbitan monooleate (soldunder the name Crill 4), Brij 72, Span 60, Span 80, sodium methyloleyltaurate, disodium oleamido mea sulfosuccinate, PEG-55 propyleneglycol oleate, sodium cocoyl isethionate, cetyl alcohol, stearylalcohol, sodium lauryl sulfoacetate, disodium laureth sulfosuccinate,sorbitan monooleate, glyceryl stearate, PEG-100 stearate. One ofordinary skill in the art would identify and recognize such emulsifiers(or surfactants behaving as emulsifiers) with low HLB numbers and suchemulsifiers (or surfactants behaving as emulsifiers) are published forexample in McCutcheon's Emulsifiers & Detergents, 2003 North AmericanEdition, pp. 238-242 (incorporated herein by reference). The emulsifierwith low HLB number may be present in the invention in the range of lessthan about 8; preferably less than about 5; and most preferably about4.7 and below. In certain embodiments, combinations of emulsifiers witha combined low HLB number may be present in the invention in the rangeof about 2 to about 10.

In certain embodiments, the composition comprises sulfur,sulfur-containing ingredient and at least one emulsifier, which has alow HLB number.

“Sulfur-containing ingredient” as used herein means any composition thatcontains organic or inorganic sulfides, inorganic sulfites, organic orinorganic mercaptans, or any other which may be used in a topical skinapplication to treat dermatological disorders (such as, withoutlimitation, acne rosacea, acne vulgaris or seborrheic dermatitis),including but not limited to cationic sulfur compounds, such as seleniumsulfide, potassium sulfide, poly-potassium sulfide, poly-calciumpolysulfide, H₂S, sulfuric acid, bisulfides, sulfur dioxide, thiols,organic salts, sodium sulfacetamide, or combinations thereof, andexcludes sulfur, as defined below.

Sulfur (or elemental sulfur) is a chemically active element and thereare several forms of elemental sulfur. Forms of elemental sulfursuitable for use in the present invention are those forms of elementalsulfur that are known to be useful in dermatological compositions,including but not limited to, colloidal, coated, enrobed, entrapped,fumed, precipitated, washed and sublimed sulfur, milk of sulfur andflowers of sulfur. The preferred form of sulfur for use in the presentinvention is precipitated sulfur.

Inorganic sulfides suitable for use in connection with the presentinvention are those inorganic sulfides known to be useful indermatological compositions and include, but are not limited to,selenium sulfide, sodium thiosulfate as well as those inorganic sulfideshaving the formula: RS, RSH, R₂S, RSSR, or RSSH, wherein R is aninorganic element that can bind ionically or covalently with sulfur.

Organic sulfides suitable for use in connection with the presentinvention are those organic sulfides known to be useful indermatological compositions and include, but are not limited to, thoseorganic sulfides having the formula: RS, R2S, RSH, R′SSR′, or R′SSH,wherein R′ is an organic compound and its salts that can bind ionicallyor covalently with sulfur. Exemplary organic sulfides include, but arenot limited to sodium thioglycolate (sodium mercaptoacetic acid), andgluathione.

Inorganic sulfites suitable for use in the present invention are thoseinorganic sulfites known to be useful in dermatological compositions,including but not limited to, sulfites and metabisulfites.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

FIG. 1 a depicts human skin before cleansing with the present invention.

FIG. 1 b depicts human skin after cleansing with the present invention.

FIG. 2 a depicts the same human skin before cleansing as FIG. 1 a, butFIG. 2 a was photographed under ultraviolet light.

FIG. 2 b depicts the same human skin after cleansing as FIG. 1 b, butFIG. 2 b was photographed under ultraviolet light.

FIG. 3 a depicts human skin after cleansing with the present inventionand is magnified (about 3×).

FIG. 3 b depicts human skin after cleansing with the present inventionand is magnified (about 3×).

FIG. 4 a depicts the same magnified human skin after cleansing as FIG. 3a, but was photographed under ultraviolet light.

FIG. 4 b depicts the same magnified human skin after cleansing as FIG. 3b, but was photographed under ultraviolet light.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

In certain embodiments, the composition comprises sulfur, asulfur-containing ingredient, at least one emulsifier with a high HLBnumber and at least one emulsifier with a low HLB number, wherein thecombined HLB number is low. In certain embodiments, the compositioncomprises sulfur, a sulfur-containing ingredient, at least oneemulsifier with a high HLB number and at least one emulsifier with a lowHLB number.

An embodiment of the invention is a composition comprising thefollowing:

TABLE 3 Ingredient Weight % Water 47.66 Glycerin 99% 2.00 Methyl Paraben0.15 Propyl Paraben 0.15 Allantoin 0.10 Edetate Sodium 0.20 SodiumMethyl Oleyltaurate (Tauranol MS) 9.15 Disodium Oleamido MEASulfosuccinate 3.85 (Mackanate OM) PEG-55 Propylene Glycol Oleate (Antil141 1.35 Liquid) Sodium Cocoyl Isethionate (Tauranol I-78C) 8.50 SodiumLauryl Sulfoacetate (and) Disodium 4.50 Laureth Sulfosuccinate(Stepan-Mild LSB) Cetyl Alcohol (Crodacol C95) 2.00 Stearyl Alcohol(Crodacol S95) 1.50 Sorbitan Monooleate (Crill 4) 2.00 Glyceryl Stearate& PEG 100 Stearate 2.00 (Arlacel 165) Butylated Hydroxytoluene (“BHT”)0.15 Alpha-Bisabolol natural 0.10 Sulfur, precipitated 5.00 PEG-150Pentaerythrityl Tetrastearate 0.15 Aloe Vera 1X Decolorized Gel 0.10Sodium Thiosulfate 0.15 Sulfacetamide Sodium 11.24 Fragrance 27160 0.10

Another embodiment of the invention is a composition comprising thefollowing:

TABLE 4 Ingredient Weight % Water 49.16 Glycerin 99% 2.00 Methyl Paraben0.15 Propyl Paraben 0.05 Allantoin 0.10 Edetate Sodium 0.20 SodiumMethyl Oleyltaurate (Tauranol MS) 9.15 Disodium Oleamido MEASulfosuccinate 3.85 (Mackanate OM) PEG-55 Propylene Glycol Oleate (Antil141 1.35 Liquid) Sodium Cocoyl Isethionate (Tauranol I-78C) 6.50 SodiumLauryl Sulfoacetate (and) Disodium 4.50 Laureth Sulfosuccinate(Stepan-Mild LSB) Cetyl Alcohol (Crodacol C95) 1.00 Stearyl Alcohol(Crodacol S95) 1.00 Sorbitan Monooleate (Crill 4) 2.00 Glyceryl Stearate& PEG 100 Stearate 2.00 (Arlacel 165) Butylated Hydroxytoluene (“BHT”)0.15 Alpha-Bisabolol natural 0.10 Sulfur, precipitated 5.00 PEG-150Pentaerythrityl Tetrastearate 0.15 Aloe Vera 1X Decolorized Gel 0.10Sodium Thiosulfate 0.15 Sulfacetamide Sodium 11.24 Fragrance 27160 0.10

Another embodiment of the invention is a composition comprising thefollowing:

TABLE 5 Ingredient Weight % Water (preferably purified water) 48.66Glycerin USP 2.00 Methyl Paraben NF 0.15 Propyl Paraben NF 0.05Allantoin 0.10 Sodium Methyl Oleyltaurate (Tauranol MS) 9.15 DisodiumOleamido MEA Sulfosuccinate 3.85 (Mackanate OM) Propylene Glycol (and)PEG-55 Propylene 1.35 Glycol Oleate (Antil 141 Liquid) Sodium CocoylIsethionate (Tauranol I-78C) 6.50 Sodium Lauryl Sulfoacetate (and)Disodium 4.50 Laureth Sulfosuccinate (Stepan-Mild LSB) Cetyl Alcohol(Crodacol C95) 1.00 Stearyl Alcohol (Crodacol S95) 1.50 SorbitanMonooleate (Crill 4) 2.00 Glyceryl Stearate & PEG 100 Stearate 2.00(Arlacel 165) Butylated Hydroxytoluene (“BHT”) 0.15 Alpha-Bisabololnatural 0.10 Sulfur, precipitated 5.00 Edetate Disodium 0.20 PEG-150Pentaerythrityl Tetrastearate 0.15 (Crothix) Aloe Vera 1X DecolorizedGel IX 0.10 Sodium Thiosulfate 0.15 Sulfacetamide Sodium 11.24 Fragrance0.10 Total Percent 100% *Water, USP (as a pharmaceutical processing 3.00aid) (additional) *An additional 3% water is added as a pharmaceuticalprocessing aid after all the other components total 100%.

In the present invention, sulfur and sodium sulfacetamide compositionsare formulated in stable, non-malodorous compositions, which arepreferably cleansers. The composition may be in the form of emulsions,suspensions, lotions, creams, and gels, preferably emulsions orsuspensions.

One of ordinary skill in the art would understand that the viscosity ofthe embodiments may be modified for delivery and cosmetic reasonswithout altering the invention. In this specification, unless otherwisespecified, the viscosity is measured on a Brookfield RVTD viscometer atabout 25° C.±1° C. for 1 minute with the spindle set for 20 rpm (spindleset RV). It is preferred to measure the viscosity at about 24 hoursafter the composition was made. The preferred viscosity is about 5000 toabout 70,000 cps, more preferably about 35,000 cps to about 45,000 cps,more preferably about 25,000 to about 35,000 cps, most preferably about30,000 cps. Another preferred viscosity is about 26,000 cps. Anotherpreferred viscosity is about 41,000 cps.

Viscosity Measuring Technique

The compositions of the present invention may be tested for viscosity inthe following manner. All viscosities in this specification are measuredin this manner unless otherwise noted. A Brookfield viscometer model No.RVTD with RV spindle set. The spindle used should be one in which thereading is mid-range for good accuracy.

In this viscosity testing, the following procedure should be used.Dispense 140 ml of Standard into a 150 ml beaker. The standard should betested twice, one standard below the expected sample viscosity and oneabove. The temperature of the standard should be 25 C+−1 C. Use a waterbath or other appropriate device to maintain constant temperature duringmeasurement. Lower the viscometer head with spindle attached slowly intostandard until the surface of the standard is located within the grooveabove the spindle disk. Zero the viscometer readout. Adjust the spindlespeed to 20 rpm. Turn on the viscometer and allow it to rotate for oneminute. Take a reading, and multiply the reading by the chartmultiplication factor for the spindle. The resulting reading should bethe same as the standard used within +/−10%. Then, the sample of theinvention is equilibrated to 25 C+/−1 C. The amount of sample and thesize of the sample container should be such that the test spindle can beplaced into the sample container with no obstruction. The temperature ismaintained at 25C+/−1 C. Lower the viscometer head with spindle attachedslowly into sample until the surface is located within the groove abovethe spindle disk. Zero the viscometer readout. Adjust the spindle speedto 20 rpm. Turn on the viscometer and allow it to rotate for one (1)minute. Take the reading and calculate with the chart multiplicationfactor.

In a preferred embodiment, at least one emulsifier with a low HLB number(e.g., without limitation, Crill 4 NF or sodium monoleate with HLB=about4.7) is present to help balance at least one emulsifier with high HLBnumber and help stabilize the emulsion.

Preferred emulsifiers (or surfactants which may behave as emulsifiers)include, but are not limited to, sodium methyl oleyltaurate, disodiumoleamido mea sulfosuccinate, PEG-55 propylene glycol oleate, sodiumcocoyl isethionate, cetyl alcohol, stearyl alcohol, sorbitan monooleate,glyceryl stearate (and) PEG 100 stearate, and sodium lauryl sulfoacetate(and) disodium laureth sulfosuccinate.

Additionally, it may be desirable to have one or more humectant in thecomposition to hydrate the skin. Humectants may include those known tothose of ordinary skill in the art to hydrate the skin, preferably,without limitation, glycerin.

Further, it may be desirable to have one or more moisturizer in thecomposition to moisturize the skin. Skin subject to these disorders maybe sensitive and dry, and therefore moisturizers may be beneficial.Moisturizers may include those known to those of ordinary skill in theart to moisturize the skin, preferably, without limitation, allantoin,bisabolol (preferably alpha-bisabolol natural), and aloe vera gel(preferably aloe vera 1X decolorized gel).

In some embodiments, preservatives, fragrances and coloring may beadded. Preservatives may include those known to those of ordinary skillin the art and preferably, without limitation, methyl paraben, propylparaben, and butylated hydroxytoluene (“BHT”).

EXAMPLE 1

One batch of the present invention as described in Table 3 was preparedand tested for viscosity and stability.

The viscosity measurements were taken as described in the specification.The top of the batch measured about 7150 cps, middle about 7850 cps andbottom about 6800 cps.

As noted above, sulfanilamide is the result of degradation reactionswithin the composition, and a sufficient amount of sulfanilamide causesmalodor in a composition. As seen below, the composition did notdegrade.

The composition was divided into three sub-batches. One sub-batch wasstored in 55 gallon drums, which were flushed with nitrogen and afterfilling, packaged with a nitrogen blanket. Another sub-batch waspackaged in tubes, which had been flushed with nitrogen. A thirdsub-batch, under a nitrogen blanket, was deposited on a non-woven clothand sealed in a package.

The batches were tested initially and after being stored at 25° C. for 1month, the tubes and cloths were also tested after being stored at 40°C. for 1 month, and the cloth was also tested after being stored at 40°C. for 1 month. Additionally, the compositions were visually observedfor discoloration, which is also a sign of degradation, and is notcosmetically acceptable.

TABLE 6 (bulk tested) Initial 1 Month 25° C. Sulfacetamide (% LC) 106.1106.5 % RSD (n = 3) 0.1 0.3 Sulfanilamide 0.29 0.91 (% w/w) % RSD (n =3) 2.00 1.04 Sulfur (avg % LC) 102.9 101.7 % RSD (n = 3) 0.3 0.7 pH 7.16.9 Appearance Light yellow Light yellow lotion, lotion, No visibleseparation No visible of layers separation of layers % RSD means percentrelative standard deviation. n = 3 means that three cloths were tested.% LC means percent of amount of the ingredient to be claimed on thelabel of an approved FDA product (for example, if the label claimed 5%sulfur and the product had 5% sulfur, % LC would be 100%). Label claimsin this specification were assumed to be 5% sulfur and 10% sodiumsulfacetamide for these type of calculations.

TABLE 7 (tubes tested) Initial 1 Month 25° C. 1 Month 40° C.Sulfacetamide 105.5 105.2 102.7 (% LC) % RSD (n = 3) 0.6 1.4 1.4Sulfanilamide 0.53 0.94 1.90 (% w/w) % RSD (n = 3) 3.03 1.05 1.69 Sulfur(avg % LC) 102.8 102.7 102.2 % RSD (n = 3) 0.3 3.0 1.6 pH 7.1 6.9 6.9Appearance Light Light yellow lotion, Light yellow yellow No visiblelotion, lotion, separation of layers No visible No visible separation ofseparation layers of layers

TABLE 8 (cloth tested) 1 Month 1 Month 2 Month 2 Month Initial 25° C.40° C. 25° C. 40° C. Sulfacetamide 422.6 419.2 408.0 411.5 379.0(mg/cloth) % RSD (n = 3) 5.4 9.7 5.1 6.5 2.9 Sulfanilamide 0.69 1.112.74 1.68 5.46 (% w/w) % RSD (n = 3) 3.02 1.75 1.53 10.84 10.3 Sulfur201.9 208.4 207.5 203.3 194.5 (mg/cloth) % RSD (n = 3) 4.4 10.4 6.9 8.493.76 Appearance Yellow Yellow Yellow Yellow Yellow cloth cloth clothcloth cloth No No No No No discol- dis- dis- dis- dis- orationcoloration coloration coloration coloration

EXAMPLE 2

Additionally, the composition as set forth in Table 3 was prepared and0.15% fluorescein sodium was added. Then, human skin (the cheek adjacentto the nose and the back of the hand) and cloth were both moistened withwater. The cloth with the composition was applied and the compositionwas allowed to remain for a few minutes. Then, the skin was rinsed offand patted dry.

FIGS. 1 a, 1 b, 2 a, and 2 b are all photos of the cheek skin adjacentto the nose. FIGS. 3 a, 3 b, 4 a, and 4 b are all photos of the upperside (or back) of the hand.

As can be seen in the “before cleansing” photos of FIGS. 1 a and 2 a,there are blackheads on the lower left side. In FIG. 2 a, the smallwhitish dots are probably coming from the sebum at the opening of thesebaceous follicle (the natural fluorescence is produced by action of P.acnes on the sebum). After cleansing, the same skin area has noblackheads (FIG. 1 b), indicating excellent cleansing. FIG. 2 b showsnumerous yellow dots, which are Fluorescein added to track the presenceof the composition. These dots show the deposition and retention of thecleanser within the skin surface and pilosebaceous openings afterrinsing.

FIGS. 3 a, 3 b, 4 a, and 4 b are all “after cleansing” photos of theback of the hand. As seen in FIGS. 3 a and 3 b, the furrows appear cleanand indicate penetration into the crevices of the skin and goodcleansing. The yellow fluorescent dots in most furrows of FIGS. 4 a and4 b also indicate excellent deposition and retention of the presentinvention.

EXAMPLE 3

The composition set forth in Table 5 was formulated as follows. Whenpossible all reaction vessels were covered to reduce water loss due toevaporation in the following process. The sodium methyl oleyltaurate washeated to about 60-65° C. for at least about 12 hours before dispensing.First, the sodium methyl oleyltaurate and disodium oleamido MEAsulfosuccinate were mixed at 300 rpm for about 15 minutes. Then, themixture was heated to about 70-75° C. while stirring at 300 rpm. Thenpropylene glycol (and) PEG-55 propylene glycol oleate; sodium laurylsulfoacetate (and) disodium laureth sulfosuccinate, and sodium cocoylisethionate were added in order and mixed for 15 more minutes andmaintained at about 70-75° C. This was the “First Mixture.”

Then, in a separate tank, the initial water amount (which is about 37%of the total water used in Example 2) was added (and water was purgedwith nitrogen for at least two hours) and then glycerin was added andmixed at about 26 rpm and heated to about 70-75° C. for about 14-25minutes. Then the combination was mixed and heated to 70° C. for about 9to about 50 minutes. One of ordinary skill in the art would understandthat the rpm and mixing times will vary according the batch size, anddissolution of the ingredients. Then the methyl paraben and propylparaben is added while mixing and maintaining about 70° C. and mixingfor about 6 to 22 minutes. It may be preferable to take some mixture offthe bottom and add to the top until all materials are completelydissolved. The edetate disodium and allantoin were added whilemaintaining about 70° C. and mixing at about 15 rpm for about 10minutes. This mixture was in the “Main Tank.” The mixture that residedin the Main Tank is the “Second Mixture.”

The First Mixture was added to the Main Tank while mixing at about 60rpm for about 8 to 18 minutes. This addition occurred slowly to avoidfoaming. The combined mixture is then mixed for about an additional 15minutes at about 15 rpm and at about 70-75° C.

In another tank, cetyl alcohol and stearyl alcohol were mixed at about225 rpm and about 70-75° C. for about 30 minutes to about 1 hour 29minutes. While mixing, sorbitan monoleate, glyceryl stearate (and)PEG-100 stearate, butylated hydroxytoluene and alpha-bisabolol wereadded in order, allowing for complete liquefaction after each addition.This was the “Third Mixture.” Then the Third Mixture was added to theMain Tank slowly to avoid foaming and mixed for about 15 more minutes atabout 15 rpm and about 70-75° C.

Then, water (about 26.1% of the total water used in Example 2) wasplaced in a separate tank and purged with nitrogen for at least about 2hours. Then the tank was heated to about 60-65° C. Sulfur was added andhomogenized for 15 minutes to get a smooth suspension. After rinsing thehomogenizer with water and removing it, a mixer was used at about 300rpm. Sodium methyl oleyltaurate was then added and mixed for about 10minutes. PEG-150 pentaerythrityl tetrasterate was added and mixed untilthe composition was uniform. 60-65° C. was the approximate temperatureand mixing occurred for approximately another 15 minutes until thecomposition was uniform. This was the “Fourth Mixture.”

The Fourth Mixture was added to the Main Tank and a vacuum of about −0.8to −0.6 bar was again pulled. The Main Tank was mixed for not less thanabout 15 minutes at about 15 rpm and about 70-75° C. Then, the Main Tankwas cooled to about 37-40° C. to achieve homogeneity.

In a separate vessel, water (about 1.9% of the total water used inExample 2) was purged with nitrogen for at least about 2 hours and mixedat about 400 rpm and about 60-65° C. while edetate sodium was added.Mixing occurred until materials were completely dissolved and then thevessel was cooled to about 35-40° C. Aloe vera gel was then added andthen mixed to get a clear homogeneous solution, while about 35-40° C.was maintained. This was the “Fifth Mixture.” The Fifth Mixture was thenadded to the Main Tank. A vacuum of about −0.8 to −0.6 bar was drawn andmaintained for at least about 15 minutes. The mixing speed was about 18rpm and the temperature was about 35-40° C.

In a separate vessel, water (about 29% of the total water used inExample 2) was purged with nitrogen for at least about 2 hours. Thenitrogen blanket was maintained for the following additions, while therewas mixing at about 225 rpm and heating to about 35-40° C. The followingwere added in order, allowing for complete dissolution after eachaddition: sodium thiosulfate and sulfacetamide sodium. This was the“Sixth Mixture.” Then, the Sixth Mixture was added to the Main Tankunder vacuum (about −0.8 to −0.6 bar) and mixed at about 26 rpm and thenthe Main Tank was cooled to about 30 to 35° C.

Fragrance was then added and mixed for about 15 minutes at about 26 rpm.Vacuum was drawn to about −0.8 to −0.6 bar and the Main Tank was mixedfor about 1 hour. Then it was cooled to about 25 to 30° C.

The vacuum was broken and water (about 5.8% of the total water used inExample 2), which had been purged with nitrogen for at least 2 hours,was added. Vacuum of about −0.8 to −0.6 bar was drawn and mixingoccurred for about 1 hour at about 26 rpm.

This embodiment was then packaged in plastic jars which had been floodedwith nitrogen, or poly-lined fiber drums with LDPE bags, which had beenflooded with nitrogen. Later, this composition was applied to non-wovencloth.

EXAMPLE 4

One batch of the present invention as described in Table 5 and Example 3was prepared, except that the additional 3% water was not added aprocessing aid, deposited on a non-woven cloth, sealed in a package andtested for stability.

The composition on the cloth was tested initially and after being storedat about 25° C., about 60% relative humidity and at about 40° C., about70% relative humidity for 1, 2 and 3 months. Additionally, thecompositions were visually observed for discoloration, which is also asign of degradation, and is not cosmetically acceptable.

TABLE 9 1 month 1 month 2 month Initial 25° C./60% 40° C./75% 25° C./60%Sulfacetamide 422.6 419.2 408.0 411.5 (mg/cloth) % RSD (n = 3) 5.4 9.75.1 6.5 Sulfanilamide 0.69 1.11 2.74 1.68 (% w/w) % RSD (n = 3) 3.021.75 1.53 10.84 Sulfur 201.9 208.4 207.5 203.3 (mg/cloth) % RSD (n = 3)4.4 10.4 6.9 8.49 Appearance Yellow Yellow Yellow Yellow cloth clothcloth cloth No No No No discoloration discoloration discolorationdiscoloration 2 month 3 month 3 month 40° C./75% 25° C./60% 40° C./75%Sulfacetamide 379.0 419.2 360.0 (mg/cloth) % RSD (n = 3) 2.9 6.6 3.7Sulfanilamide 5.46 1.97 7.12 (% w/w) % RSD (n = 3) 10.3 0.88 9.41 Sulfur194.5 207.26 204.32 (mg/cloth) % RSD (n = 3) 3.76 0.74 1.12 AppearanceYellow cloth Yellow cloth Yellow cloth No No No discolorationdiscoloration discoloration

It is to be understood that while the invention has been described inconjunction with the detailed description thereof, that the foregoingdescription is intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims. Otheraspects, advantages, and modifications are evident from a review of thefollowing claims.

1-26. (canceled)
 27. A method of treating acne vulgaris comprisingapplying to skin a composition comprising sulfur, a sulfur-containingingredient, and at least one emulsifier which has a low HLB number, andat least one emulsifier which has a high HLB number, wherein thecombined HLB number of all emulsifiers is no greater than about 8.28-30. (canceled)
 31. The method of treating acne vulgaris of claim 27further comprising at least one humectant.
 32. The method of treatingacne vulgaris of claim 27 further comprising one or more moisturizers.